Objectives: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer. Methods: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research. Results: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data. Conclusions: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.
|Number of pages||7|
|Journal||Urologic Oncology: Seminars and Original Investigations|
|Early online date||5 May 2015|
|Publication status||Published - Jul 2015|
Bibliographical noteWe are grateful to the EORTC Quality of Life Group for having supported the development of the PROMOTION Registry. We also acknowledge the essential contribution of Alessandro Perreca and Salvatore Soldati, from the GIMEMA Health Outcomes Research Unit, for data management. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
- Bladder cancer
- Clinical decision making
- Clinical trials
- Patient-reported outcomes
- Quality of life